[Informe de investigación]Se espera que el mercado de servicios de liofilización para productos biofarmacéuticos crezca de 2.051,41 millones de dólares en 2022 a 3.586,55 millones de dólares en 2028; se estima que registrará una tasa compuesta anual del 9,9 % entre 2023 y 2028.
El crecimiento del mercado de servicios de liofilización para productos biofarmacéuticos se atribuye a la creciente demanda de productos liofilizados y al rápido crecimiento de los servicios de liofilización y fabricación por contrato en todo el mundo. .
El mercado de servicios de liofilización para productos biofarmacéuticos está segmentado según el tipo de servicio, el usuario final y la región. El informe ofrece información y un análisis en profundidad del mercado, enfatizando parámetros como los servicios de liofilización para las tendencias del mercado biofarmacéutico, los avances tecnológicos, la dinámica del mercado y el análisis del panorama competitivo de los principales actores del mercado.
Servicios de liofilización para el mercado biofarmacéutico: ideas estratégicas
Servicios de liofilización para el mercado biofarmacéutico global
Servicios de liofilización para el mercado biofarmacéutico:
Servicios de liofilización para el mercado biofarmacéutico: Perspectivas del mercado
El rápido aumento de la fabricación por contrato y los servicios de liofilización impulsa el crecimiento del mercado de servicios de liofilización para productos biofarmacéuticos
El mercado de productos biofarmacéuticos continúa expandiéndose en todo el mundo, lo que puede ser el principal motor de crecimiento para la industria farmacéutica. La fabricación de productos biofarmacéuticos parenterales se ha ampliado recientemente a medida que se han aprobado más productos biológicos terapéuticos. Las empresas de biotecnología subcontratan organizaciones de fabricación por contrato (CMO) para satisfacer sus necesidades de llenado y acabado y reducir el riesgo de contaminación microbiana. Las empresas biofarmacéuticas dependen de organizaciones de fabricación por contrato (CMO) para proporcionar capacidad y capacidades según sea necesario; en algunos casos, los CMO proporcionan una gran parte de la producción de una empresa.
Establecer capacidades y operaciones internas de liofilización requiere equipo especializado y experiencia, lo cual es costoso y pérdida de tiempo. Sin embargo, la subcontratación es más barata y aumenta la eficiencia de los procesos de fabricación. Además, permite a las empresas de biotecnología redirigir recursos a otras áreas. Por lo tanto, los desarrolladores de medicamentos y las compañías biofarmacéuticas subcontratan dichas operaciones a las CMO para ahorrar producción general y costos de rendimiento. Hace unos años, la industria CMO era un nicho de mercado de servicios que ofrecía capacidad de fabricación adicional o servicios específicos a las empresas de biotecnología. Actualmente, muchas empresas de biotecnología subcontratan diversos servicios, desde el desarrollo de fármacos en sus primeras etapas hasta la fabricación a escala comercial. A medida que la industria de la biotecnología está pasando de la producción a gran escala a terapias específicas y específicas (medicina personalizada), está aumentando la demanda de capacidades operativas flexibles, escalas de producción y operaciones de múltiples productos. Debido a todos estos factores, la inclinación hacia las CMO está creciendo. Uno de esos CMO que proporciona instalaciones especializadas y líneas dedicadas para operaciones de liofilización es Jubilant HollisterStier Contract Manufacturing & Servicios. La CMO ofrece llenado/finalización estéril de la Fase I a través de un inyectable estéril comercial y un conjunto completo de servicios de liofilización. Para mantenerse al día con la creciente demanda de sus servicios, Jubilant está instalando un nuevo liofilizador de 385 pies cuadrados. Por lo tanto, la creciente capacidad y disponibilidad de los CMO biofarmacéuticos impulsan el crecimiento del mercado de servicios de liofilización para productos biofarmacéuticos.
Mercado global de servicios de liofilización para productos biofarmacéuticos, por tipo de servicio: 2022 vs 2028
Servicios de liofilización para el mercado biofarmacéutico: ndash; Por información basada en el tipo de servicio
Según el tipo de servicio, el mercado global de servicios de liofilización para productos biofarmacéuticos se segmenta en fabricación comercial, desarrollo de ciclos de liofilización, fabricación clínica y servicios analíticos de liofilización. El segmento de fabricación comercial tuvo la mayor participación de mercado en 2022. Se espera que el segmento de desarrollo del ciclo de liofilización registre la CAGR más alta durante el período de pronóstico.
Servicios de liofilización para el mercado de productos biofarmacéuticos: Según información basada en el usuario final
Según el usuario final, el mercado global de servicios de liofilización para productos biofarmacéuticos se segmenta en empresas farmacéuticas y de biotecnología, institutos de investigación y otros. El segmento de empresas farmacéuticas y de biotecnología tuvo la mayor participación de mercado en 2022. Se espera que el segmento de institutos de investigación registre la CAGR más alta durante el período de pronóstico.
Las empresas en el mercado de servicios de liofilización para productos biofarmacéuticos adoptan productos inorgánicos y estrategias orgánicas como fusiones y adquisiciones. A continuación se enumeran algunos desarrollos clave recientes del mercado:
- En noviembre de 2022, LTI anunció su participación en el desarrollo, la ingeniería de procesos y la preparación de material clínico para la vacuna candidata contra la tuberculosis ID93/GLA-SE. . La vacuna contra la tuberculosis ha alcanzado con éxito la fase 2 de pruebas clínicas. Este estudio representa el primer informe sobre la liofilización exitosa de una candidata a vacuna de subunidad termoestable que contiene un adyuvante a base de emulsión.
- En mayo de 2022, Jubilant HollisterStier LLC celebró un acuerdo de cooperación por 149,6 millones de dólares con Army Contracting. Command, en coordinación con la Oficina Ejecutiva del Programa Conjunto para la Defensa Química, Biológica, Radiológica y Nuclear (JPEOCBRND) en nombre de la Autoridad de Investigación y Desarrollo Biomédico Avanzado (BARDA), dentro del Departamento de Salud y Servicios Humanos de EE. UU.
- En octubre de 2021, PCI Pharma Services (PCI) anunció que había firmado un acuerdo definitivo para adquirir Lyophilization Services of New England, Inc. (LSNE), una importante organización de fabricación y desarrollo por contrato (CDMO) con sede en Bedford. , New Hampshire, de la firma global de capital privado Permira. La adquisición suma cinco instalaciones aprobadas por la FDA en EE. UU. (New Hampshire, Wisconsin) y Europa (España), y se espera la aprobación de una sexta en los próximos meses. Además, se están desarrollando tres instalaciones adicionales. Estas instalaciones fortalecerán su red global de 30 sitios.
- En julio de 2021, Albany Molecular Research, Inc. (AMRI) anunció que cambiará su nombre a Curia, a partir del 12 de julio de 2021. El nuevo nombre refuerza el posicionamiento estratégico de la compañía como CDMO global de extremo a extremo, aplicando su experiencia científica y amplias capacidades desde investigación y desarrollo (I+D) hasta fabricación comercial para permitir a sus clientes farmacéuticos y biotecnológicos promover nuevos productos importantes que mejoren vidas.
Perfiles de empresas: Servicios de liofilización para el mercado biofarmacéutico
- Soluciones médicas ATTWILL
- Axcellerate Pharma LLC
- Labyrinth Biopharma LLC
- Berkshire Sterile Manufacturing
- PCI Pharma Services
- Curia Global Inc
- Emergent BioSolutions Inc
- Jubilant HollisterStier LLC
- Biofortuna
- Lyophilization Technology Inc.
- SYNERLAB GROUP
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
This text is related
to segments covered.
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
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to country scope.
Frequently Asked Questions
Companies operating in the market are ATTWILL Medical Solutions; Axcellerate Pharma LLC; Labyrinth Biopharma LLC; Berkshire Sterile Manufacturing; PCI Pharma Services; Curia Global Inc; Emergent BioSolutions Inc.; Jubilant HollisterStier LLC; Biofortuna; Lyophilization Technology Inc.; and SYNERLAB GROUP.
Lyophilization is a process of isolating a solid substance from a solution. It is also known as freeze-drying is a process. The process is carried by freezing the solution and evaporating under vacuum. It helps in optimizing lyophilization cycle times and improves stability for critically complexes of injectable during the parenteral product development.
Global lyophilization services for biopharmaceuticals market is segmented by region into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. North America is likely to continue its dominance in the lyophilization services for biopharmaceuticals market during 2023–2028. The US holds the largest share of the market in North America and is expected to continue this trend during the forecast period.
The growth of market is likely to grow due to factors such as rising demand for lyophilized products and rapid growth in contract manufacturing and lyophilization services across the world are expected to boost the growth of the global lyophilization service for biopharmaceuticals market. However, the market is likely to get impacted by the demerits associated with lyophilization process during the forecast period.
Based on service type, the global lyophilization services for biopharmaceuticals market is divided into commercial manufacturing, lyophilization cycle development, clinical manufacturing, and freeze-drying analytical services. The commercial manufacturing segment held the largest share of the market in 2022. The lyophilization cycle development segment is expected to grow at the highest CAGR during the forecast period.
Based on end user, the global lyophilization services for biopharmaceuticals market is divided into pharmaceutical and biotechnology companies, research institutes, and others. The pharmaceutical and biotechnology companies segment held the largest share of the market in 2022. The research institutes segment is expected to grow at the highest CAGR during the forecast period.
The List of Companies - Lyophilization Services for Biopharmaceuticals Market
- ATTWILL Medical Solutions
- Axcellerate Pharma LLC
- Labyrinth Biopharma LLC
- Berkshire Sterile Manufacturing
- PCI Pharma Services
- Curia Global Inc
- Emergent BioSolutions Inc
- Jubilant HollisterStier LLC
- Biofortuna
- Lyophilization Technology Inc.
- SYNERLAB GROUP
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published and advised several client across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organization are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
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- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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